The researchers at Merck concluded the XL7 is a valuable tool for both inline monitoring of suspension formulations, and delivering batch-to-batch consistency during manufacture.
During the production of pharmaceutical suspension formulations, controlling the dispersion of hydrogels is critical to achieving the desired rheological properties. A study conducted by Merck research laboratory aimed to determine whether the Hydramotion XL7 Process Viscometer could serve as a process analytical technology (PAT) tool for real-time monitoring during batch manufacturing.
The researchers tested the viscometer by running different batches with varying conditions, and looked at how the viscosity changed over time as the hydrogel was mixed. The viscosity profiles were then compared to those obtained by the conventional Brookfield viscometer.
The results showed that the poorly dispersed hydrogel exhibited a distinct in-line viscosity profile from the properly dispersed hydrogel. The XL7's high sensitivity was able to detect the difference between hydrogel concentrations within the dispersion, and accurately track variations in real-time.
The XL7 also provided viscosity profiles that were linearly correlated with those from the offline Brookfield viscometer with a cubic fit of .99.
The dynamic viscosity profile obtained by the XL7 showed low variability and good inter-batch reproducibility for a properly dispersed hydrogel. In the process, any deviation from the expected viscosity trend could signal batch failure or inconsistent dispersion homogeneity. Therefore an in-line viscometer can be used in manufacturing to monitor the batch-to-batch consistency and respond in real-time.
The researchers at Merck concluded the XL7 is a valuable tool for both inline monitoring of suspension formulations, and delivering batch-to-batch consistency during manufacture.
Whitepaper conducted at a Merck research laboratory available here: